Archive | Regulatory

FDA Grants Orphan Drug Designation to Cavrotolimod for Merkel Cell Carcinoma

The FDA has granted an orphan drug designation to cavrotolimod (AST-008) for the treatment of patients with Merkel cell carcinoma (MCC), according to an announcement from Exicure, Inc.1

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Posted in Melanoma News, Regulatory, Publications

Alkermes Announces FDA Orphan Drug Designation for Nemvaleukin Alfa for Treatment of Mucosal Melanoma

Alkermes plc (Nasdaq: ALKS) today announced that nemvaleukin alfa (“nemvaleukin”, formerly referred to as ALKS 4230), the company’s investigational engineered interleukin-2 (IL-2) variant immunotherapy, has been granted orphan drug designation for the treatment of mucosal melanoma by the U.S. Food and Drug Administration (FDA).

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Posted in Melanoma News, Regulatory, Publications

Tebentafusp Named FDA Breakthrough Therapy for Advanced Eye Cancer

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Immunocore‘s tebentafusp (IMCgp100) for HLA-A2 positive, inoperable, or advanced uveal melanoma — a common and difficult-to-treat form of eye cancer — the company announced in a press release.

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Posted in Melanoma News, Regulatory, Publications

The Paradoxical Behavior of microRNA-211 in Melanomas and Other Human Cancers

Cancer initiation, progression, and metastasis leverage many regulatory agents, such as signaling molecules, transcription factors, and regulatory RNA molecules.

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Posted in Melanoma News, Regulatory, Publications